Recall archive / FDA device enforcement
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 26494... — FDA record Z-0207-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm) 5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm) 5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm) 5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm) 8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm) 8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm) 8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)
- Reason
- Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- all lots
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0207-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Code/Product Name/UDI-DI: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 10884521067196 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 10884521067202 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 10884521067219 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 10884521067226 5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm) 50192253008171 5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm) 50192253008195 5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm) 50192253008201 5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm) 50192253008218 8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm) 10192253012453 8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm) 10192253012972 8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm) 10192253012996 All Lots |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 29, 2025
- Recall initiation date
- Sep 18, 2025
- Center classification date
- Oct 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.